EXENT Analyser Recall Issued by FDA
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The Binding Site Group, Ltd. is recalling one EXENT Analyser (Model IE800.A, Software v1.0.20) distributed nationwide in the US due to a quality control issue that may lead to inaccurate M-protein detection.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 28, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
The EXENT Analyser was reported to mark plates 2 and 3 as passed even though QC had not been performed, despite samples being measured. This Class II recall was initiated voluntarily by the firm on April 16, 2026.
Which Products Are Affected
- Brand Name: EXENT Analyser
- Product Name: EXENT Analyser
- Model/Catalog Number: IE800.A
- Software Version: 1.0.20
- UDI: 05051700020886
- Serial Number: 101150
- Quantity: 1 unit
- Distribution: US Nationwide
- Recall Number: Z-2362-2026
What You Should Do
Consumers should follow instructions provided in the firm's notification letter regarding the affected device.
Why This Matters
The issue creates a potential for false or missed detection of M-protein and falsely elevated or decreased M-protein concentration readings.
Source
FDA Recall Z-2362-2026 - The Binding Site Group, Ltd.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (889 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 28, 2026.
Frequently Asked Questions
Common questions about this FDA recall.